Kornimate/medical-research-clean huggingface dataset:
evaluation of diphenhydramine hydrochloride effects in subjects with occasional sleeplessness

Conditions: Occasional Sleeplessness

Summary: the present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.

diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of the ethanolamine classes with known sleep-inducing properties and is approved by the food \& drug administration to reduce the time to sleep onset in individuals having difficulty falling asleep. the goal of the study is to investigate diphenhydramine versus placebo with regard to several sleep parameters, including time to sleep onset, in healthy adult subjects suffering from occasional sleeplessness.

Eligibility criteria:
inclusion criteria: * be male or female subjects, ≥18 years of age to 55 years of age, who report that they are currently experiencing occasional sleeplessness characterized by difficulty initiating sleep (ie, taking ≥30 minutes to fall asleep) on average 2-4 times per week for less than 1 month; * be in good general health without clinically significant disease (no previously diagnosed sleep disorders); * if female, have a negative screening pregnancy test and agree to be on approved methods of birth control throughout the study exclusion criteria: * have a clinically significant illness within 30 days of screening; * are taking medication that could interfere with the study medication; * have been under a clinician's care for insomnia treatment and control within the past year or has a history of insomnia or is currently taking prescription medications for insomnia; * are currently taking medications known to effect sleep function; * have current or past history of serious, severe or unstable physical or psychiatric illness; * have current diagnosis of severe urinary retention; * have current diagnosis of untreated narrow angle glaucoma; * had participated in a clinical drug study or used an investigational new drug during the previous 30 days; * have any clinically significant or abnormal finding in physical examination, vital signs, ecg, or clinical laboratory tests that may affect the subject's safety or outcome of the study;
study to evaluate the long-term safety of rusfertide (ptg-300) in subjects with polycythemia vera

Conditions: Polycythemia Vera

Summary: the goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. subjects who complete dosing with rusfertide until the end-of-treatment visit of a phase 2 rusfertide study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.

this is an open-label study designed to assess the long-term safety and efficacy of rusfertide. this study aims to provide long-term rusfertide treatment to subjects who complete dosing until the end-of-treatment of a previous phase 2 rusfertide study and are likely to continue benefiting from treatment with rusfertide based on their improved control of hematocrit levels \<45% and reduced need for therapeutic phlebotomies. this study will provide long-term rusfertide treatment to these subjects and obtain data on safety and efficacy of long-term treatment with rusfertide.

Eligibility criteria:
inclusion criteria: * subject who has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous phase 2 study of rusfertide. * subject understands the study procedures, is willing and able to adhere to study requirements and agrees to participate in the study by giving written informed consent. key exclusion criteria: * subject who, in the opinion of the investigator, should not participate in the study. * subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study. * pregnant or lactating females. * women of childbearing potential (wocbp) who do not agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 30 days after the last dose of study drug. * men with partners of childbearing potential who do not agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 90 days after the last dose of study drug. * men who do not agree to use a condom during the study and for 90 days after the last dose of study drug regardless of the partner's childbearing potential. * a female subject intends to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study drug. * a male subject intends to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study drug. * plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose. * subject with hypersensitivity to rusfertide or to any of the excipients. * in the investigator's opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.
n-care project: enhancing asian-pacific collaboration

Conditions: Whole Genome Sequencing; Genetic Disease; Critical Care, Intensive Care; Nanopore Sequencing

Summary: through asian-pacific multinational collaboration, we aim to utilize third-generation genome sequencing to rapidly diagnose genetic diseases in critically ill infants and young children, achieving the goal of early diagnosis for targeted treatment.

a group of individuals with specific characteristics was selected. genetic studies were arranged for participants who provided their consent.

Eligibility criteria:
inclusion criteria: 1. age: infant/newborn less than 18 months 2. admitted to intensive care unit 3. at least one of the following conditions a. specific anomaly highly suggestive of a genetic etiology * multiple birth defects * single major malformation that required intervention (surgery or medication) * significantly abnormal ekg * significant hypotonia b. children with high-risk stratification on assessment of a brief resolved unexplained event (brue) with any of the following: * recurrent severe infection events * recurrent or prolonged seizures * unexplained cardiopulmonary resuscitation (cpr) * suspect inborn error of metabolism exclusion criteria: 1. infants with a definitive non-genetic diagnosis: ex as below a. an infection with normal response to therapy b. isolated prematurity c. transient hypoglycemia d. isolated unconjugated hyperbilirubinemia e. isolated transient neonatal tachypnea f. those where the clinical course can be explained without genetic testing 2. confirmed genetic diagnosis explains illness 3. lack of consent: families who do not consent to genetic testing or data sharing. 4. infants without sufficient dna sample quality/quantity: where the quality or quantity of the dna sample is inadequate for sequencing.
effects of virtual reality hypnosis on anxiety, pain and comfort in oncology patients during a port-catheter placement procedure

Conditions: Cancer

Summary: the port-catheter (pac) is a longterm venous access device, frequently used in oncology patients. the pac is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. patients can experience pain in the incision area after implantation, as well as anxiety before, during and after implantation. virtual reality hypnosis (vrh) is an innovative technique delivering clinical hypnosis to patients through virtual reality (vr). the clinical applications of vrh are still little known. we will assess the anxiety, comofrt, pain perception and pain unpleasantness of 102 cancer patients scheduled to receive a pac. the patients will be randomly divided into two groups. thefirst group will benefit from the usual care for the placement of the pac (i.e., local anaesthesia), while the second will benefit from the vrh in addition to the usual care. pain perception, pain unpleasantness, anxiety, satisfaction, absorption, dissociation will be evaluated before and after the intervention.


Eligibility criteria:
inclusion criteria: * low auditory and/or visual acuity precludes the use of the device. * head or face wounds precluding the use of the device. * schizophrenia, dissociative disorder or any other psychiatric disorder. * non-proficiency in french (research language). * patient under 18 years old. * phobia of deep water. * dizziness.
desensitization for highly sensitized recipients of pancreas transplantation

Conditions: Type 1 Diabetes; Rejection of Pancreas Transplant; Desensitization

Summary: this is an observational study for patients with type 1 diabetes, whom are already scheduled to have desensitization treatment to help increase the chance of receiving a pancreas transplant.the study staff will be looking at medical records in order to collect past, present and future information for each subject's medical condition and/or transplant. there are no additional study tests, procedures or devices needed for our analysis.

please note that this study is observational. the treatment of each patient will be at the discretion of the care physician. the study investigators will only be performing data collection and analysis. post transplant all patients will receive one additional cycle of plasma exchange with a moderate dose of intravenous immunoglobulin (ivig) (0.4 mg/kg). antibody titers will be monitoring prior to plasma exchange and immediately following the treatment. at this point, since donor antigens are known, only antibodies to these antigens will be tested to minimize cost. we anticipate that in some patients, especially if the original titer of donor-specific antibody (dsa) was high (\> 1:128), a rise in dsa will be observed following transplant. if indeed dsa will be present, additional monitoring will be initiated and the patient will be treated further with plasma exchange/ivig cycles, with antibody monitoring before and immediately after each cycle. if no dsa are detected, patients will be monitoring on a every other day schedule for the first week; weekly for the next 3 weeks and monthly up to 6 months post transplant. additional testing will be performed in the event of any clinical evidence of graft dysfunction, or following sever infection events. patient will be followed to 12 month post transplant or until one of the end points is reached: 1. pancreas graft failure: defined by return of hyperglycemia and resume of insulin therapy; 2. patient death due to all causes with functioning graft

Eligibility criteria:
inclusion criteria: * pancreas transplant recipients with elevated panel reactive antibody levels of \>50% and who have received desensitization treatment and subsequently receive their transplantation at northwestern memorial hospital (nmh). exclusion criteria: * no exclusion criteria exist.
safety and efficacy of sa09012 in asthma

Conditions: Mild to Moderate Bronchial Asthma

Summary: clinical study to evaluate the efficacy, dose-response and safety of sa09012 in bronchial asthma patients


Eligibility criteria:
inclusion criteria: * diagnosis or presence of asthma within 3 months of the prestudy visit 1. increase in pef ≥ 20% or ≥ 60l/min from baseline value after taking bronchodilator at screening or within the 3 months of the prestudy visit 2. increase in fev1 ≥ 12% and ≥ 200ml from baseline value after taking bronchodilator at screening or within the 3 months of the prestudy visit * fev1 or pef between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit * having signed an informed consent exclusion criteria: * patient who has severe asthma * patient who has any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study other protocol-defined inclusion/exclusion criteria may apply * patient with an ast or alt \> 2x uln (upper limit of normal) in the screening visit * patient with more than 10 pack year of cigarettes history

Keywords: asthma
modified functional magnetic stimulation treatment for constipation improvement

Conditions: Constipation

Summary: to prove the modify functional magnetic stimulation could improve constipation.

1. permission： any agent without effecting gastrointestinal motility or defecation is allowed. 2. inhibition： from test day to the next day(48 hours),it's not allowed to take any medication treatment which might affect digestive system or excretory system.

Eligibility criteria:
inclusion criteria: * patients who age between 20\~60 years old and have suffered from chronic constipation for more than 6 months will be enrolled in this study. exclusion criteria: * patients with implantation chip of brain * patients with implantation of pacemaker * patients with heart transplantation * patients are embedded electronic and life support products. * people who have be implanted metal、electronic devices、artificial joints or fixator. * patients with hemiplegia * patients with peripheral neuritis * patients with prostate abnormalities * patients with pregnancy * patients with fever * patients with injure * patients with heart disease * patients with consciousness disturbance * patients with organic constipation * patients with kidney stone * patients with ureteric calculus

Keywords: constipation stimulation treatment
the use of chaperone in routine anorectal examination

Conditions: Exanimation

Summary: background and aim: the use of chaperone in routine anorectal examination of women attending to coloproctology clinics has not been studied to this date. the aim of this study is to compare the patients' perception and preference regarding the presence of a chaperone during their first anorectal examination. patients and methods: adult women will be randomly selected to be examined with or without the presence of a female chaperone. after that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present in that clinical situation. the patients will prospectively enrolled in one of the two groups of this randomized trial during a period of two years.

the use of chaperone in routine anorectal examination of women attending to coloproctology clinics has not been studied to this date. however, there are some guidance saying says that doctors should offer the patient the option of a chaperone wherever possible before conducting an intimate examination. the aim of this study is to compare the female patients' perception and preference regarding the presence of a chaperone during their first anorectal examination conduct by a male physician. adult women will be investigated during their first visit to a coloproctology clinic at university hospital. only senior professionals will be examining the patients. this will be a prospectively randomized trial. patients will be selected to be examined with or without the presence of a female chaperone. after that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present during the anorectal examination. the enrollment period will be two years from july 2018. sample size estimated for the study is 188 patients (94 in each study group).

Eligibility criteria:
inclusion criteria: * adult female patients; * first visit to our coloproctology clinic; * signed consent form exclusion criteria: * patients previously submitted to anorectal examination; * refusal of participation.
a placebo controlled study to assess efficacy and safety of certolizumab pegol in the treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: patients will be assigned to one of three treatment groups. study medication is administered over a 52 week study duration.


Eligibility criteria:
inclusion criteria: * male and female, aged at least 18 years old at the screening visit. * a clear chest x-ray within 3 months prior to baseline visit. * a diagnosis of adult-onset ra (of at least six months duration but not longer than 15 years prior to screening) as defined by the 1987 american college of rheumatology classification criteria. * active ra disease at screening and baseline as defined by: * ≥9 tender joints. * ≥9 swollen joints. and fulfilling 1 of the following 2 criteria: * ≥30 mm/hour esr (westergren), or * crp \>15 mg/l. * must have received a stable dose of mtx with or without folic acid for at least 3 months prior to baseline visit. the minimum dose is 10 mg mtx weekly. * patient must be willing to attend for a week 52 x-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent. exclusion criteria: * a diagnosis of any other inflammatory arthritis e.g., psoriatic arthritis or ankylosing spondylitis. * a secondary, non-inflammatory type of arthritis (e.g. oa or fibromyalgia) that in the investigator's opinion is symptomatic enough to interfere with evaluation of the effect of cdp870 on the patient's primary diagnosis of ra. * a history of an infected joint prosthesis at any time with prosthesis still in situ. * does not meet exclusionary concomitant medication criteria. * a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time. * patients at a high risk of infection in the investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).

Keywords: rheumatoid arthritis, cdp870 certolizumab pegol, cimzia
htn app for htn control and cardiovascular health among african-americans

Conditions: Hypertension

Summary: the purpose of this study is to test the hypertension (htn) app-based intervention to see if it is more effective in improving uncontrolled htn and htn self-care among africian-americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care.


Eligibility criteria:
inclusion criteria: * african-american (aa) adults that are established patients at neighborhood healthsource in minneapolis, minnesota. * receives primary care (i.e., has designated primary care provider) at the partnering fqhcs and intent to continue care there for next 12 months * african american race/ethnicity * men and women aged ≥18 years * uncontrolled htn (defined as stage 2 htn with a bp ≥140/90 mmhg \[as per 2017 american college of cardiology/american heart association htn guidelines32\] at most recent outpatient evaluation, with or without bp medications) * documented diagnosis of htn in ehr * at least 1 office visit at the partnering fqhcs in the prior year * smartphone ownership (supporting ios or android systems) * active email address and willingness to utilize it throughout the study * basic internet navigation skills (for example, can search for information on websites, open and send emails) * access to the internet on at least a weekly basis (such as at home, a family member's or friend's home, church, library/community center, school/university, internet café, etc.)? exclusion criteria: * diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app). * no primary care provider at partnering fqhc
microelectrode recordings from the vagus nerve in awake humans

Conditions: Epilepsy

Summary: this anchillary project uses a refined technique of ultrasound-guided microneurography of the human cervical vagus nerve, an approach developed by professor vaughan macefield and used safely to-date in 44 prior study participants. the overall goal of this project is to build upon prior data obtained using this approach by undertaking a detailed neurophysiological investigation of the human vagus nerve and to identify the nerve fibers activated during vagal nerve stimulation (vns) in participants with implanted vns devices in response to different stimulation parameters. in addition to providing data in unprecedented detail into the physiology of the human vagus nerve, this project will investigate different stimulus intensities, durations and frequencies that differentially excite myelinated and unmyelinated nerve fibers. these results will inform the csp and guide future development of novel neural interfaces for vns for various clinical applications.


Eligibility criteria:
inclusion criteria: * the participant is greater than or equal to (≥)18 years and is less than or equal to (≤) 40 years of age * english speaking * medicare covered or equivalent health insurance from a partner country exclusion criteria: * pregnant * smokes and is unwilling to abstain from smoking on the day of the experiment. * inability or unwillingness to provide written informed consent. * individuals with difficulty standing unassisted for 5 minutes during the tilt-table testing * individuals found to have a significant carotid artery plaque or intima-media thickness \> 1 mm as assessed by ultrasonography during the ultrasound-screening steps of the study visit * vagus nerve not visible on ultrasound * vns electrodes are not in a suitable location to allow for microelectrode insertion * any other clinical reasons deemed by the investigators